MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TOTAL ARTIFICIAL HEART (STAH); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number	P/N 500101
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, a syncardia authorized distributor reported the three-way stopcock cannot be connected with the tester because the hole on the tester is too small.
Additional Manufacturer Narrative
The stopcock will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Additional Manufacturer Narrative
Device history record (dhr) review for 70cc tah lot# 125579 was performed and no anomalies were found and all manufacturing was performed to specifications.Visual inspection of the actual device or components could not be completed due to the device not being returned from the customer.A photograph was provided as evidence of the malfunction.While the picture indicates that the hole on the tester is too small to connect the three-way stopcock, it is not definitively a device malfunction and cannot be tested further as it was not returned.Failure investigation for this complaint confirmed the reported issue from the provided photograph.Additional testing could not be completed as the device was not returned and no historical or manufacturer provided data gives any insight into this issue.It is an anomaly that has only presented as an issue for this single complaint.The customer complaint was not replicated as the device was not returned; the root cause of the reported three-way stopcock connection problem was unable to be conclusively determined and does not constitute a device malfunction.There was no reported adverse impact to the patient.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
Event or Problem Description
The customer, a syncardia authorized distributor reported the three-way stopcock cannot be connected with the tester because the hole on the tester is too small.

• Brand Name: SYNCARDIA 70CC TOTAL ARTIFICIAL HEART (STAH)
• Common Device Name: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17005584
• Report Number: 3003761017-2023-00084
• Device Sequence Number: 14993367
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (Y/N): N
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: P/N 500101
• Device Lot Number: 125579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male